Recall Z-0614-2018— Siemens Medical Solutions USA, INC

Name: FDA recall Z-0614-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, INC, initiated 2017-08-22, terminated 2018-08-21. It names one FDA 510(k) clearance: K133580. Product: Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus. Reason: The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen.

Recalling firm: Siemens Medical Solutions USA, INC
Classification: Class II
Status: Terminated
Initiated: 2017-08-22
Terminated: 2018-08-21
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133580 — ARTIS ONESiemens Medical Solutions USA, Inc.·cleared 2014-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

Reason for recall

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

Data sourced from openFDA. This site is unofficial and independent of the FDA.